Martin-Liberal, Juan http://orcid.org/0000-0003-2552-5172
Hollebecque, Antoine
Aftimos, Philippe
Jungels, Christiane
Martin-Romano, Patricia
Rodon, Jordi
Kremer, Jill Dolores
Zhang, Wei
Bendell, Johanna
Funding for this research was provided by:
Eli Lilly and Company
Article History
Received: 2 May 2020
Revised: 13 June 2020
Accepted: 13 July 2020
First Online: 3 August 2020
Ethics approval and consent to participate
: Institutional review boards of each centre approved the study protocol before initiation of patient enrolment (Supplementary Table InternalRef removed). The study adhered to the Declaration of Helsinki, the International Conference on Harmonization Guidelines for Good Clinical Practice, Council for International Organizations of Medical Sciences, and applicable local regulations. All patients provided informed consent before enrolment. The study was registered in ClinicalTrials.gov (NCT02597036).
: Lilly provides access to all individual participant data collected during the trial, after anonymisation, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once they are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data-sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report and blank or annotated case report forms, will be provided in a secure data-sharing environment for up to 2 years per proposal. For details on submitting a request, see the instructions provided at ExternalRef removed.
: J.M.L. received lecture fees from Astellas Pharma, Bristol–Myers Squibb, Merck Sharp & Dohme (MSD), Novartis, Pierre Fabre, Pfizer, and Roche; advisory fees from Bristol–Myers Squibb, MSD, Novartis, Pierre Fabre, and Roche; and travel grants from Bristol–Myers Squibb, MSD, Novartis, Pierre Fabre, Pfizer, Roche and Ipsen. A.H. received honoraria/advisory fees from Gritstone Oncology, Eisai Co., Ltd., Amgen, Servier and Merck Serono. P.A. received honoraria/advisory fees from Novartis, Roche, MacroGenics, G1 Therapeutics, Servier, Synthon, Amcure, Amgen and Boehringer Ingelheim; and travel grants from MSD, Pfizer and Roche. C.J. received travel grants from PharmaMar S.A., Bayer and Ipsen. P Martin-Romano: Principal/sub-Investigator of Clinical Trials for AbbVie, Adaptimmune, Aduro Biotech, Agios Pharmaceuticals, Amgen, Argen-X Bvba, Arno Therapeutics, Astex Pharmaceuticals, AstraZeneca, AstraZeneca Ab, Aveo, Bayer Healthcare Ag, Bbb Technologies Bv, Beigene, Bioalliance Pharma, Biontech Ag, Blueprint Medicines, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol–Myers Squibb, Bristol–Myers Squibb International Corporation, Ca, Celgene Corporation, Cephalon, Chugai Pharmaceutical Co., Clovis Oncology, Cullinan-Apollo, Daiichi Sankyo, Debiopharm S.A., Eisai, Eisai Limited, Eli Lilly, Exelixis, Forma Therapeutics, Gamamabs, Genentech, Gilead Sciences, Glaxosmithkline, Glenmark Pharmaceuticals, H3 Biomedicine, Hoffmann La Roche Ag, Incyte Corporation, Innate Pharma, Institut De Recherche Pierre Fabre, Iris Servier, Janssen Cilag, Janssen Research Foundation, Kura Oncology, Kyowa Kirin Pharm. Dev., Lilly France, Loxo Oncology, Lytix Biopharma As, Medimmune, Menarini Ricerche, Merck Kgaa, Merck Sharp & Dohme Chibret, Merrimack Pharmaceuticals, Merus, Millennium Pharmaceuticals, Molecular Partners Ag, Nanobiotix, Nektar Therapeutics, Nerviano Medical Sciences, Novartis Pharma, Octimet Oncology Nv, Oncoethix, Oncomed, Oncopeptides, Onyx Therapeutics, Orion Pharma, Oryzon Genomics, Ose Pharma, Pfizer, Pharma Mar, Philogen S.P.A., Pierre Fabre Medicament, Plexxikon, Rigontec Gmbh, Roche, Sanofi Aventis, Sierra Oncology, Sotio A.S, Syros Pharmaceuticals, Taiho Pharma, Tesaro, Tioma Therapeutics, Wyeth Pharmaceuticals France, Xencor, Y’s Therapeutics, Research Grants from AstraZeneca, BMS, Boehringer Ingelheim, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi. P Martin-Romano also disclosed non-financial support (drug supplied) from AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Johnson & Johnson, Lilly, Medimmune, Merck, NH TherAGuiX, Pfizer, Roche. J.R.A. received personal fees and other from Novartis, Kelun Pharmaceuticals/Klus Pharma, Spectrum Pharmaceuticals Inc, Pfizer, Bayer. Personal fees from Eli Lilly and Company, Orion Pharmaceuticals, Roche Pharmaceuticals, Ellipses Pharma, Certera, Ionctura SA. Also conflict with European Journal of Cancer, VHIO/Ministero De Empleo Y Seguridad Social, Chinese University of Hong Kong, SOLTI, Elsevier, GlaxoSmithKline, ESMO, Department of Defense, Merck Sharp & Dohme, Louisiana State University, Huntsman Cancer Institute, Cancer Core Europe, Karolinska Cancer Institute, King Abdullah International Medical Research Center, WIN Consortium, Janssen, Tocagen, Symphogen, BioAlta, GenMab, CytomX, Kelun-Biotech, Takea-Millenium, and Ipsen. J.D.K. and W.Z. are employees and stockholders in Eli Lilly and Company. J.B. received grants and other from Gilead, Genentech/Roche, BMS, Five Prime, Eli Lilly and Company, Merck, MedImmune, Celgene, Taiho, Macrogenics, GlaxoSmithkline, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, BI, Daiichi Sankyo, Bayer, Incyte, Apexigen, Array, Sanofi, Agios, Ipsen, Merrimack, Oncogenex, Evelo, Forma, Innate, Arch Oncology, Prelude Therapeutics, Amgen, Seattle Genetics, Bicycle Therapeutics, and Relay Therapeutics. Received grants from EMD Serono, Koltan, SynDev Rex, Abbvie, Onyx, Takeda, EISAI, Celldex, Xytomx, Nektar, Armo, Boston Biomedical, Tarveda, Tyrogenex, Marshall Edwards, Pieris, Mersana, Calithera, Blueprint, Merus, Effector, Novocare, Arrys, Tracon, Sierra, Jacobio, Unum Therapeutics, Vyriad, Harpoon, ADC, Pfizer, Millennium, Imclome, Acerta Pharma, Rgenix, Bellicum, Gossamer Bio, Arcus Bio, Tempest Tx, Shattuck Labs, Synthorx, Inc, Revolution Medicines, Inc, and Zymework. Conflict with Phoenix Bio, Cyteir, Molecular Partners, Torque, Tizona, Janssen, Tolero, TD2 (Translational Drug Development), Moderna Therapeutics, Tanabe Research Laboratories, Beigene and Continuum Clinical.
: The trial was sponsored by Eli Lilly and Company.